Kornimate/medical-research-clean huggingface dataset:
a study to determine the immunogenicity and safety profile of csl limited's influenza virus vaccine compared to a us licensed comparator influenza virus vaccine

Conditions: Influenza

Summary: the purpose of this study is to determine the immunogenicity and safety profile of csl limited's influenza virus vaccine compared to a us licensed comparator influenza virus vaccine.


Eligibility criteria:
inclusion criteria: 1. males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ; 2. written informed consent ; 3. willingness to provide a blood sample. exclusion criteria: 1. known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the study vaccines; 2. previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine; 3. known history of guillain-barré syndrome; 4. clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees f (37.8 degrees c). 5. have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders; 6. history of seizures; 7. confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder; 8. clinically significant history of malignancy 9. current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the study vaccine; 10. current immunosuppressive or immunomodulative therapy; 11. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine; 12. participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the study vaccine ; 13. vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the study vaccine. 14. current treatment with warfarin or other anticoagulants; 15. major congenital defects; 16. evidence, or history (within the previous 12 months) of drug or alcohol abuse; 17. unwillingness or inability to comply with the study protocol including completion of adverse event diary cards; 18. history of psychiatric disorders; 19. resident of long term care facility.
ivc and lung ultrasound b-lines guided decongestion in critically ill eskd patients with heart failure

Conditions: End-stage Renal Disease

Summary: the objectives of this trial are to determine whether, in critically ill eskd patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term.

the point-of-care ultrasound was thought useful in the management of fluid in critically ill patients. at present, the role of the lung and inferior vena cava ultrasound is unclear in the management of decongestion of heart failure in kidney failure (kf) patients using prolonged hemodialysis. the investigators aim to explore the effect of pre-dialysis probing with the lung and inferior vena cava to guide fluid removal as compared with conventional protocols on the improvement of heart failure symptoms in patients with kf with heart failure under prolonged hemodialysis in the short-term.

Eligibility criteria:
inclusion criteria: 1. patients meet the diagnostic criteria for end-stage renal disease; 2. indications that the patient may be experiencing signs and/or symptoms of heart failure, and based on the serum n-terminal pro-brain natriuretic peptide level of greater than 11,215. 2 ng/l; 3. patients may require prolonged intermittent renal replacement therapy due to volume overload; 4. patients ≥18 yo and ≤80 yo; 5. either the patient or a family member signs the informed consent; 6. patients will undergo at least two sessions of prolonged hemodialysis. exclusion criteria: 1. history of malignancy or psychiatric disease; 2. patients with a history of congenital heart disease or hypertrophic cardiomyopathy; 3. coagulation abnormalities, intracranial, visceral or gastrointestinal bleeding in the past 3 months, or contraindications to heparin anticoagulation; 4. the duration of prolonged hemodialysis \<8 hours; 5. ultrasound unable to monitor the inferior vena cava, or can't access the date; 6. pregnancy; 7. patients with severe respiratory failure; 8. patients with combined severe infections, such as patients with sepsis; 9. presence of pre-dialysis hypotension: systolic blood pressure \<90 mmhg; 10. other conditions deemed ineligible by physicians.

Keywords: kidney failure, chronic heart failure
vhit testing for presentation of dizziness at a comprehensive stroke center

Conditions: Stroke, Acute; Vertigo; Vertigo, Peripheral; Dizziness; Dizziness; Syndrome

Summary: the purpose of this study is to evaluate the sensitivity and specificity of the video head impulse test (vhit) device, when implemented in the acute ed setting to identify acute ischemic stroke or central pathology vs peripheral vestibular dysfunction in patient's presenting with vertigo. this study will evaluate the implementation of the device, consistency with current diagnostic standards, unnecessary administration of antithrombolytics and will further study the reduction in hospital admissions and overall healthcare costs.

in the proposed study, subjects admitted to the emergency department (ed) with symptoms of dizziness, concerning for an acute ischemic stroke, will undergo routine triage (bedside neurologic examination, head impulse testing, ct scan) and will then be tested with a vhit device to attempt to further identify the cause of dizziness, after standard of care testing has been performed. the clinician performing the vhit will be blinded to the result of the ct scan before entering their report.

Eligibility criteria:
inclusion criteria: * adults between the ages of 18-90 * admitted to the musc ed with symptomatic dizziness, concerning for a stroke vs peripheral vestibular dysfunction. exclusion criteria: * prisoners * covid + * cognitively impaired individuals
compassion focused therapy for distressing experiences

Conditions: Psychosis

Summary: this study aims to develop and test the feasibility of a new therapy called compassion focused therapy (cft) for psychosis. this therapy helps people with psychosis manage distressing experiences by building internal feelings of safeness and affiliation, and by providing contexts, practices and insights that facilitate the development of compassion to self and others. the focus is on helping people feel safe in relation to their experiences and their social worlds. cft is a promising new approach that has been successfully provided for people with a range of mental health difficulties. it is also firmly based in the most up-to-date knowledge and science about how the mind works (both normally and under stress). 9 participants will be recruited from nhs psychological therapies services for people with psychosis in south london and maudsley (slam) nhs foundation trust. following a short baseline period they will receive up to 26 weekly sessions (about 6 months) of cft with a clinical psychologist, and will provide interview and questionnaire research data at five different points during the study. at these assessment points, data will be gathered on participants' experiences, mood, perceptions of their position in the social world, and heart rate variability. the initial therapy protocol has been developed by psychologists with expertise in cft, alongside people with lived experience of hearing voices and having distressing beliefs. however, it will continue to be developed and evolve as the study progresses, and as more is learnt (e.g. from the service-user participants) about applying the model in this population. at the end of this study, the aim is to have all the information needed to run a randomised controlled trial of this therapy.


Eligibility criteria:
inclusion criteria: * over 18 years old * psychosis related diagnosis (f20-39) * distressing positive symptoms of psychosis. each participant will have been routinely screened with psyrats at their service entry assessment. on psyrats, at least one positive symptom (i.e. hallucination or delusion) will be present, and distress will be evidenced by an associated intensity score of 2 or above * willing to engage in psychological therapy * sufficient command of english language * able to provide informed consent exclusion criteria: * currently engaged in cbt, or have completed a 12+ session course of cbt within the last 3 years. if recruitment is under target, this will be relaxed to 12+ session course of cbt (cognitive behavioural therapy) within the last 6 months * currently engaged with another treatment study (e.g. medicine or therapy)
a study of carboplatin + paclitaxel and mk0683 in patients with chemotherapy-naive non-small cell lung cancer (nsclc)(0683-066)

Conditions: Neoplasms

Summary: the clinical study will evaluate safety, tolerability and pharmacokinetics of mk0683 in combination with carboplatin and paclitaxel in chemotherapy-naive nsclc patients.


Eligibility criteria:
inclusion criteria: * chemotherapy-naive patients who are histologically or cytologically diagnosed nsclc with stage iiib (not applicable of radical thoracic radiation) or stage iv * patients with normal organ function and bone marrow function exclusion criteria: * given radical thoracic radiation for nsclc or radiation for other than original lesion within 3 weeks * any peripheral neuropathy above grade 2 * any ascites, pleural effusion or pericardiac effusion which requires treatment * any uncontrolled concomitant illness * pregnant or breast-feeding

Keywords: non-small cell lung cancer (nsclc)
early versus late parenteral nutrition in the pediatric intensive care unit

Conditions: Critical Illness; Children

Summary: in the pepanic trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.


Eligibility criteria:
inclusion criteria: * all patients admitted to the picu with a strongkids score of 2 points or more upon icu admission exclusion criteria: * age of 17 years or older * patients with a dnr code at the time of icu admission. * patients expected to die within 12 hours (=moribund patients). * patient readmitted to icu after randomization to the pepanic trial, more than 48 hours after the initial discharge * patients transferred from another paediatric intensive care after a stay of more than 7 days * patients suffering from ketoacidotic or hyperosmolar coma on admission. * patients suffering from short bowel syndrome on home pn or other conditions that require home pn * patients suspicious or established inborn metabolic diseases requiring specific diet * strongkids score lower than 2 on icu admission. * premature newborns ( 37 weeks gestational age upon admission in the picu) * prior inclusion in another randomized controlled outcome study

Keywords: critical illness children nutrition metabolism
nitrous oxide for pain management of first trimester surgical abortion

Conditions: Abortion in First Trimester

Summary: the purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications.

this study has important implications in the field of pain management for surgical abortion. while no is administered in some outpatient clinics for surgical abortion, its effect on pain has not been systematically studied in a randomized controlled trial in women undergoing first trimester surgical abortion under local/oral analgesia. expanding pain management options for women undergoing abortion confers significant public health benefits.

Eligibility criteria:
inclusion criteria: * 18 years old or older, * elective pregnancy termination at gestational age of less than 11 weeks, * speak english * candidate for an in-clinic procedure. * desire local anesthesia, ibuprofen, vicodin and ativan (the usual treatment in our clinic) for managing pain exclusion criteria: * no medical problems preventing the use of nitrous oxide * no allergies to nitrous oxide, lidocaine, vasopressin, ibuprofen, vicodin or ativan * significant active upper respiratory infection * chronic obstructive pulmonary disease (copd) * intoxication * use of street drugs

Keywords: nitrous oxide pain
cervical pain and exercise in musicians

Conditions: Cervical Pain

Summary: exercise training that is one of the effective treatment methods for cervical pain, is crucial in developing mobility and stability. exercise training significantly reduces cervical pain as it advances postural alignment and neuromuscular coordination. in many single group studies on cervical pain in violin performers, it has been reported that the stabilization exercises have favorable consequences on pain relief and postural correction. but, there are no studies comparing ney and violin performers and analyzing the effectiveness of exercise training on non-specific cervical pain. the aim of this study is to search the effects of selected exercise training on pain, disability, range of motion, flexibility, strength and quality of life in ney and violin performers with non-specific cervical pain.


Eligibility criteria:
inclusion criteria: * being professional musicians * using violin or ney musical instruments * had non-specific cervical pain during 3 months exclusion criteria: * had cervical surgery in the last 3 months, discogenic pain, radiculopathy, neurological or systemic disorders, * missing exercise training session more than 2

Keywords: exercise cervical pain disabilities musicians
computerized training for individuals diagnosed with obsessive-compulsive and related disorders

Conditions: Obsessive Compulsive Disorder

Summary: obsessive-compulsive disorder (ocd) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. this study aims to build on our understanding of aberrant emotional processing in ocd. the proposed project tests whether a computerized training aimed to alter emotional processes, can relieve repetitive thoughts and behaviors.


Eligibility criteria:
inclusion criteria: * age 18 years old and older * primary diagnosis of ocd * sufficient severity of ocd symptoms * stable on psychotropic or other medication * capacity to provide informed consent exclusion criteria: * psychiatric or medical conditions that make participation unsafe * concurrent use of any medications that might increase the risk of participation * concurrent cognitive-behavioral therapy for ocd

Keywords: obsessive-compulsive disorder ocd obsessive personality disorder compulsive behavior personality disorders mental disorders anxiety disorders impulsive behavior cognition emotion emotional regulation
dysregulation of fsh in obesity: functional and statistical analysis

Conditions: Obesity; Fertility

Summary: excess maternal weight, especially obesity, influences almost every aspect of fertility, from conception to problems during pregnancy. the investigators will use novel statistical methods to clarify the hormonal changes behind reproductive health conditions. a better understanding of reproductive hormonal changes in obese women may offer a way to identify new treatments.

hypothesis. insufficient fsh (follicle-stimulating hormone) pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production. aim: to test the hypothesis that insufficient fsh pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production. the investigators will determine if exogenous fsh administered in a pulsatile fashion results in a significant increase of ovarian hormones in obese women. serial inhibin b and e2 levels will be measured in obese and normal weight women undergoing frequent blood sampling studies before and after gnrh (gonadotropin-releasing hormone) antagonist blockade.

Eligibility criteria:
inclusion criteria: * age between 21 to 39 years old with regular menstrual cycles every 25-40 days * body mass of 18.5 kg/m2-24.9kg/m2 (normal weight controls) or greater than 30.0 kg/m2 (obese group) * prolactin and thyroid-stimulating hormone (tsh) within normal laboratory ranges at screening * baseline hemoglobin \>11 gm/dl. exclusion criteria: * diagnosis of polycystic ovary syndrome (pcos), defined by the 2003 rotterdam criteria as suggested by 2012 nih workshop * history of chronic disease affecting hormone production, metabolism or clearance or use of thiazolidinediones or metformin (known to interact with reproductive hormones) * use of hormones affecting hypothalamic-pituitary-gonadal (hpo) axis (such as hormonal contraceptives) within 3 months of entry * strenuous exercise (\>4 hours of intense physical activity per week) * pregnancy * breast-feeding * current attempts to conceive * significant recent weight loss or gain

Keywords: obesity fertility infertility reproductive hormones
cardiogenomics registry

Conditions: Cardiovascular Disease

Summary: this is a continuous blood banking study that will archive plasma and blood permitting dna and plasma analysis at a future date. subjects are recruited at the time of a clinically required procedure and blood samples are collected and banked and used for future research. the main purpose of this study is to investigate the interaction of multiple phenotypes and genotypes and their impact on cardiovascular disease events and measures of atherosclerosis progression.


Eligibility criteria:
inclusion criteria: * \> 17 years of age * undergoing a clinical required cardiovascular procedure * agree to donation of blood sample * provide written informed consent and authorization for use/disclosure of phi exclusion criteria: * \< 18 years of age * refusal to donate a blood sample * refusal to provide written informed consent and authorization for use/disclosure of phi

Keywords: cardiovascular
the recurrence mechanism of venous tinnitus after boney wall reconstruction based on multimodal imaging and multiphysics coupling

Conditions: Pulsatile Tinnitus

Summary: venous tinnitus (vt) is seriously affecting the quality of life of five million patients in china. bony wall reconstruction is the main treatment method, but the postoperative recurrence rate exceeds 30%, and the specific mechanism is unclear. based on our previous work, a scientific hypothesis was put forward: the key to the recurrence of v t is pathologic remodeling of the peri-sinus bony wall mediated by the venous sinus morphology, blood flow, and pressure after surgical reconstruction. as a continuation of the national natural science foundation of china-youth project, this project intends to combine multimodal imaging technology, multiphysics coupled numerical model and machine learning method to analyze analyze the data after bone wall reconstruction in multiple dimensions: ① to explore the influence of peri-sinus bony wall morphology, venous sinus morphology, intra-sinus blood flow, intra-sinus pressure, and cerebral perfusion on the recurrence of vt using ultra-high resolution ct, vessel wall mr, 4d flow mr and asl mr imaging technology; ② to explore the influence of blood flow impact, sinus wall pressure and peri-sinus bone wall deformation on the recurrence of vt using multiphysics coupling numerical model with vessel, blood flow, bone and acoustic fields; ③ to determine the risk factors and their weights of vt recurrence using machine learning methods, and to establish a personalized surgical planning and prognostic evaluation models; thus, to verify the hemodynamic and biomechanical mechanisms of vpt recurrence to achieve personalized and effectively treatment. this project may prevent and warn the recurrence of vpt after bony wall reconstruction.


Eligibility criteria:
inclusion criteria: * patients with venous tinnitus, a rhythmic noise that follows the heart beating without external stimuli and can disappear or significantly reduce after compression of the affected side of the neck * the normal otoscopy * venous tinnitus patients with confirmed sigmoid sinus wall dehiscence with or without sigmoid sinuses enlargement, diverticula and transverse sinuses stenosis using dual-phase enhanced ct examination * preoperative dsa examination * bone wall reconstruction exclusion criteria: * contraindications for ct and mr examination * tumor and arterial abnormalities

Keywords: magnetic resonance angiography head and neck ear pulsatile tinnitus hemodynamics
a study of relatlimab plus nivolumab in combination with chemotherapy vs. nivolumab in combination with chemotherapy as first line treatment for participants with stage iv or recurrent non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Metastatic Non-small Cell Lung Cancer

Summary: the purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (pdct) and to determine if nivolumab plus relatlimab in combination with pdct improves overall response rate (orr) when compared to nivolumab plus pdct in participants with previously untreated stage iv or recurrent non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria * histologically confirmed metastatic non-small cell lung cancer (nsclc) of squamous (sq) or non-squamous (nsq) histology with stage iv a/b (as defined by the 8th international association for the study of lung cancer classification) or recurrent disease following multi-modal therapy for locally advanced disease. * eastern cooperative oncology group (ecog) performance status (ps) of less than or equal to 1 at screening and confirmed prior to randomization. * measurable disease by computed tomography (ct) or magnetic resonance resources (mri) per response evaluation criteria in solid tumor version 1.1 (recist 1.1) criteria. * no prior systemic anti-cancer treatment (including epidermal growth factor receptor (egfr) and anaplastic lymphoma kinase (alk) inhibitors) given as primary therapy for advanced or metastatic disease. exclusion criteria * participants with egfr, alk, ros-1, or known b-rapidly accelerated fibrosarcoma proto-oncogene (braf v600e) mutations that are sensitive to available targeted therapy. * untreated cns metastases. * leptomeningeal metastases (carcinomatous meningitis). * concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease). * prior treatment with an anti-programmed cell death protein 1 (pd-1), anti-programmed death-ligand 1 (pd-l1), anti-programmed death-ligand 2 (pd-l2), or anti-cytotoxic t-lymphocyte-associated protein 4 (ctla-4) antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: stage iv non-small cell lunch cancer recurrent non-small cell lung cancer metastatic non-small cell lung cancer relatlimab nivolumab chemotherapy